The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
Georgetown University
Summary
The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.
Description
The aim of this study is to evaluate whether the decision support intervention produces a clinically significant change in informed decisions about breast MRI. An informed decision is defined as a decision that is made with sufficient knowledge, and is in line with the person's preferences. The investigators will achieve this aim through a randomized controlled trial. This trial adheres to well-established design and reporting criteria for behavioral intervention studies to ensure patient safety and examine trial outcomes.\<br\> \<br\> Research Design. The main hypothesis is that participants…
Eligibility
- Age range
- 18–74 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * female * aged 18-74 years * self-identifying as Black and/or Latina * no personal history of breast cancer * English- or Spanish-speaking * having received a mammogram with normal results in the last 12 months * ≥20% lifetime breast cancer risk per the NCI Breast Cancer Risk Assessment Tool (BCRAT) Exclusion Criteria: * aged \<18 or ≥75 * pregnancy
Interventions
- BehavioralEnhanced Usual Care
Risk assessment and notification, referral to nurse practitioner (NP) at the Ralph Lauren Center (RLC)
- BehavioralDecision Support
The decision aid describes two different breast cancer screening plans: (1) annual mammography only; and (2) annual mammography plus annual breast MRI. The decision aid provides balanced information about breast MRI, including its risks, limitations, and benefits.
Location
- Georgetown UniversityWashington D.C., District of Columbia